Benchmarking study 2022

Swissmedic and the pharmaceutical companies have conducted their 10th benchmarking study of authorisation times for human medicinal products. Comparison with the approval lead times recorded by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and Swissmedic enables us to directly gauge the performance of the latter as a small, independent national authorisation agency in relation to that of large, international reference authorities.

Although analysis of throughput times for new applications for new active substances (NA NAS) across all procedures reveals a slightly longer lead time, Swissmedic's median figures are on a par with the EMA’s. The delays are attributable to the increased strain on resources during the COVID pandemic in 2020/21, when applications for medicinal products to combat or prevent the disease were given priority over other innovative new applications.

However, Swissmedic made up ground on the EMA and the FDA in terms of the delay in authorising NA NAS, with both the submission gap^[1] and the approval gap^[2] narrowing overall compared with 2021. This is primarily due to the international procedures conducted under the auspices of the Access Consortium and Project Orbis and to the increase in temporary authorisations.

Other trends and findings from the study can be found in the Executive Summary.

In connection with this, Swissmedic would also like to draw attention to the latest publication of the Centre for Innovation in Regulatory Science (CIRS): R&D Briefing 88 – New drug approvals in six major authorities 2013-2022 compares the authorisation times at Swissmedic with those of Europe, Japan, Canada, Australia and the USA (Figure 1). When comparing the Executive Summary and R&D Briefing 88 from CIRS, it should be noted that the inclusion criteria for applications are not identical, which may lead to small numerical differences.

^[1] _{The submission gap is defined as the time (median) between the date of submission to the reference authority and the date of submission to Swissmedic.}

^[2] _{The approval gap is defined as the time (median) between the date of approval by the reference authority and the date of approval by Swissmedic.}